(281 days)
ATRISORB®-D FreeFlow™ Barrier is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. ATRISORB®-D FreeFlow™ Barrier has been shown to reduce bacterial colonization of the barrier.
The ATRISORB®-D FreeFlow™ Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline exists as a sterile, synthetic flowable polymeric solution composed of poly(DL-lactide) (PLA) dissolved in N-methyl-2-pyrrolidone (NMP). It is mixed with doxycycline hyclate prior to formation to give a 4% doxycycline concentration. The barrier precipitates to a firm consistency upon contact with water and bioabsorbs over time. One sterile unit consists of a pouched syringe with 715 mg of the ATRISORB® polymer formulation, a syringe with 35 mg doxycycline hyclate, a blunt tip cannula, and a product insert. The barrier functions by isolating the regenerative surgical site from adjacent gingival connective tissue and epithelium, facilitating population of the site with cells from the periodontal ligament and adjacent alveolar bone. The doxycycline hyclate reduces bacterial colonization of the barrier and surgical site.
Here's a breakdown of the acceptance criteria and the study details for the ATRISORB®-D FreeFlow™ Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device and proving the additional claim of reducing bacterial colonization. The acceptance criteria are largely implied by the need to show superiority or equivalence to the predicate in key areas, and the device performance is reported based on the clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (Biocompatibility/Non-toxicity) | - Pyrogenicity: Non-pyrogenic (LAL test). |
- Tissue Irritation (In Vivo): No significant tissue irritation observed in two nonclinical dog studies.
- Biocompatibility (Predicate): Extensive biocompatibility studies on predicate (ATRISORB® GTR Barrier) and ATRISORB®-D Barriers (varying doxycycline concentrations) support safety. |
| Sterilization Efficacy | - Device is terminally sterilized by Cobalt-60 gamma irradiation. - Gamma irradiation at levels up to 39.4 kGy does not significantly alter chemical structure, potency, or ability of doxycycline hyclate to form clinically acceptable barriers. |
| Physical/Handling Characteristics (Simulated Use) | - All ATRISORB®-D FreeFlow™ Barriers (with four different PLA molecular weights) passed simulated use test criteria, verifying appropriate molecular weight limit. - Average thickness (0.474-3.584 mm) is slightly less than predicate's (0.729-3.178 mm), supporting suitability for intended use. |
| Doxycycline Release (In Vitro) | - Greater than 90% cumulative release of doxycycline from barriers into water at 24 hours. |
| Doxycycline Bioactivity (In Vitro) | - ATRISORB®-D Barrier with 5% doxycycline showed bioactivity against periodontal pathogens (Actinobacillus actinomycetemcomitans and Porphyromonas gingivalis) in time kill assay and agar diffusion techniques. |
| Reduction of Bacterial Colonization (Clinical Study - Primary Objective) | - ATRISORB®-D FreeFlow™ Barrier treatment group demonstrated significantly greater reductions for total anaerobes and counts of P. intermedia/P. nigrescens compared to the ATRISORB® GTR Barrier control. - Reductions approaching significant levels for F. nucleatum counts.
- Doxycycline levels in gingival crevicular fluid were consistently higher than minimum inhibitory concentrations of common periodontal pathogens. |
| Clinical Efficacy (Secondary Objective - to be reported later) | - Efficacy endpoints (horizontal attachment level, vertical attachment level, probing depth, and percent defect closure) at Month 6.
(Note: This data was not reported in the provided summary but was an objective of the study.) |
| Bioabsorption | - The barrier bioabsorbs over several months, remains intact during the critical period for regeneration, and eliminates the need for a second surgical procedure. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated as a single number. The "six-month clinical study" was conducted at "three different centers." While the number of subjects and defects isn't provided, it was a comparative study between two treatment groups.
- Data Provenance: Prospective clinical study. The country of origin is not explicitly stated in the provided text, but generally, FDA submissions imply studies conducted within or recognized by the US regulatory framework.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the text. Given the nature of a clinical study for a periodontal device, "ground truth" would typically come from clinical assessments performed by trained dental professionals (e.g., periodontists or dentists) and microbiological analysis. However, the exact number and qualifications of these experts are not specified.
4. Adjudication Method for the Test Set
- This information is not provided in the text. Clinical studies often employ blinding and/or independent adjudication for outcome assessments, but the specific method is not mentioned here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study involving AI assistance was not done. This device is a physical barrier for guided tissue regeneration, not an AI diagnostic or assistance tool. Therefore, the concept of "human readers improving with AI" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is a medical device (a bioabsorbable barrier itself), not a software algorithm.
7. The Type of Ground Truth Used
- The ground truth in the clinical study was established by:
- Microbiological analysis: Direct measurement of total anaerobic bacterial counts and specific periodontal pathogens (P. intermedia/P. nigrescens, F. nucleatum).
- Clinical parameters: Measured changes from baseline for horizontal attachment level, vertical attachment level, probing depth, and percent defect closure (though these efficacy endpoints were to be reported later).
- Doxycycline levels: Measurement of doxycycline in gingival crevicular fluid.
8. The Sample Size for the Training Set
- This concept is not applicable to this device. This is a physical medical device, not a machine learning model that requires a training set. The "development" and "testing" involved in-vitro characterization, animal studies, and human clinical trials, which are different from machine learning training and testing.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable as there is no "training set" in the machine learning sense for this device.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.